《使用个案安全性报告进行药品不良反应信号检测的比值失衡法的报告规范》要点解读与思考
Interpretation and Reflection on the REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance(READUS-PV)
何娜 1李晓桐 2程吟楚 3吴紫阳 4翟所迪1
作者信息
- 1. 北京大学第三医院 药学部,北京 100191;北京大学医学部 药物评价中心,北京 100191
- 2. 美国匹兹堡大学 药学院,宾夕法尼亚州 匹兹堡 15213
- 3. 北京大学第三医院 药学部,北京 100191;北京大学医学部 药物评价中心,北京 100191;美国哈佛大学医学院与哈佛朝圣者医疗保健研究所 人群医学系,马萨诸塞州 波士顿 02215
- 4. 苏州大学附属第一医院 药学部,江苏 苏州 215006
- 折叠
摘要
药物安全性评价应贯穿药品上市前后整个生命周期.近些年来,基于个案安全性报告如FDA不良事件报告系统(FAERS)数据库的比值失衡法广泛用于检测药品不良反应信号,为后续的药物安全性研究提供研究假设.然而,现有研究存在报告不清晰、不完整,以及研究结论对研究结果过度推断等情况.鉴于此,国际多学科学者制定并发布了《使用个案安全性报告进行药品不良反应信号检测的比值失衡法的报告规范(READUS-PV)》.本文对该报告规范进行简要总结,并结合设计、实施相关研究的注意事项对该报告规范的核心要点进行分析,以期为研究人员未来更好地开展和报告此类研究提供参考.
Abstract
Drug safety evaluation should be integrated throughout the entire lifecycle of a drug,from pre-market to post-market.In recent years,the disproportionality analyses based on individual case safety reports such as the FDA adverse event reporting system(FAERS)has been widely used for detecting adverse drug reaction signals,providing research hypotheses for subsequent drug safety studies.However,existing studies often suffer from unclear or incomplete reporting and over-interpretation of research findings.In response to these issues,an international multi-disciplinary group of scholars developed and published the REporting of A Disproportionality Analysis for DrUg Safety Signal Detection Using Individual Case Safety Reports in PharmacoVigilance(READUS-PV).This article provides a brief summary of the reporting standards,analyzes the core points of the guideline in conjunction with considerations for the appropriate design and implementation of related studies,aiming to offer researchers a reference for better conducting and reporting such studies in the future.
关键词
药物警戒/比值失衡法/个案安全性报告/不良反应/报告规范Key words
pharmacovigilance/disproportionality analysis/individual case safety report/drug safety/reporting standards引用本文复制引用
出版年
2024
NETL
NSTL
万方数据